FDA Seeks Input on FDCA § 301(ll) Prohibition

July 30, 2008

As we previously reported, Section 912 of the FDA Amendments Act (“FDAAA”) added a new prohibition to the Federal Food, Drug, and Cosmetic Act (“FDCA”).The new prohibition, found at FDCA § 301(ll) (21 U.S.C. § 331(ll)), prohibits the introduction into commerce of any food that contains an approved drug or a licensed biologic.It also prohibits the introduction of a food containing a drug or biologic for which substantial clinical investigations were initiated and made public.There are four narrow exceptions to this prohibition, including a first-to-market exception.As we previously noted, the § 301(ll) prohibition may have far reaching consequences for the development of new functional food and dietary ingredients.The full impact will remain unknown until FDA determines how to resolve thenumerous interpretative issues presented by the provision in the absence of legislative history.

On July 29, 2008, FDA published a Federal Registernotice inviting public comment on the possible interpretations of the prohibition and their potential effects on industry and consumers. Comments may be submitted to FDA until October 27, 2008.

The notice does not discuss the various interpretations FDA may consider or has considered.Instead, the notice invites comments to a series of open-ended questions about the interpretation of various ambiguous terms and the possible impact of the § 301(ll) prohibition.Among other things, FDA asks for comment on ambiguities in the prohibition and exceptions including the meaning of the following terms:

1. “drug”: how should FDA determine the identity of a drug?For purposes of section 301(ll) should FDA consider the chemical structure of a substance?

2.“substantial clinical investigations”: are clinical investigations limited to studies in humans or do they include studies in animals?Should clinical studies in humans bar the use of that substance in animal feed?When are clinical investigations in humans and/or animals substantial?

3. “marketed in food”: substances that were “marketed in food” before they were approved as a drug are excepted from the prohibition.FDA questions whether “marketed in food” means something different than “marketed as food,” the term used in the exclusionary clause for dietary supplements, 21 U.S.C. 321(ff), and interpreted in the Pharmanex litigation.FDA also asks for input as to the significance of “marketing in food” outside the United States.

4. “an independent biological or therapeutic effect”: substances that are used “to enhance the safety of the food supply” and do not have an “independent biological or therapeutic effect” are also excepted from the prohibition.FDA asks for input on the meaning of “a biological [and] a therapeutic effect” and when such an effect is “independent.”

FDA also requests comment on the range of products subject to the prohibition and the likely consequences to products in those categories.In particular, FDA requests information on how the prohibition would affect marketing of infant formula, dietary supplements, animal feed, and food contact substances.

Perhaps most importantly, the § 301(ll) prohibition does not exempt substances that were permitted before the enactment of FDAAA.Its impact may therefore extend beyond new functional food and dietary ingredients and bar products that are currently legally marketed.FDA asks for examples of foods that may be affected and the consequences of prohibiting these products for the consumers that use (and rely on) these products.

Clearly, FDA is grappling with interpreting FDCA § 301(ll) prohibition.Given FDA’s discretion in interpreting the prohibition, and its potential widespread and serious impact, industry would be well advised to seize this opportunity to influence FDA’s thinking and provide the Agency with information that will facilitate a reasonable construction of the law.